Date Initiated by Firm |
October 27, 2003 |
Date Posted |
October 29, 2003 |
Recall Status1 |
Terminated 3 on March 24, 2004 |
Recall Number |
Z-0001-04 |
Recall Event ID |
27549 |
510(K)Number |
K020436
|
Product Classification |
unknown device name - Product Code IZL--
|
Product |
Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain |
Code Information |
serial #PK10058 |
Recalling Firm/ Manufacturer |
Sedecal USA, Inc 2910 N Arlington Heights Rd Arlington Heights IL 60004-1551
|
For Additional Information Contact |
Mr. Devan Moser 847-394-6960
|
Manufacturer Reason for Recall |
A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.
|
FDA Determined Cause 2 |
Other |
Action |
An 'Important Safety Notice' dated 10/27/03 was sent to the one direct account on the same date, informing them of the non-compliances with the performance standard and requesting them to call Sedecal at 800-920-9525 to arrange for the modification of the x-ray unit at no cost to the user. |
Quantity in Commerce |
1 unit |
Distribution |
Vermont |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = IZL-- and Original Applicant = SEDECAL S.A.
|